MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN PUREWICK DISPOSABLE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Pain (1994); Fungal Infection (2419)

Event Date 09/02/2022

Event Type  Injury  

Event Description

It was reported that the purewick female external catheter was placed by hospital staff while the customer was an inpatient in a progressive care unit.The device caused painful irritation and a sensitive tissue reaction to mucosal tissue, causing bleeding.After five months of hospital discharge, they continued to have vaginal and suspected fungal vulvular problems.The saturated catheter did not remove all the urine and caused a bacterial or fungal growth area.Incapacitated patients become victims of secondary infections.It was unknown what medical intervention was provided.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd was unable to determine the associated labeling to review.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.

Event Description

It was reported that the purewick female external catheter was placed by hospital staff while the customer was an inpatient in a progressive care unit.The device caused painful irritation and a sensitive tissue reaction to mucosal tissue, causing bleeding.After five months of hospital discharge, they continued to have vaginal and suspected fungal vulvular problems.The saturated catheter did not remove all the urine and caused a bacterial or fungal growth area.Incapacitated patients become victims of secondary infections.It was unknown what medical intervention was provided.

• Brand Name: UNKNOWN PUREWICK DISPOSABLE
• Type of Device: UNKNOWN PUREWICK DISPOSABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16503564
• MDR Text Key: 310887926
• Report Number: 1018233-2023-01554
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 06/18/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female